Clinical trial · Interventional
Improved Function and Quality of Life for Older Patients Receiving Radiotherapy, Part II
Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This cluster randomized controlled pilot study is designed to test the feasibility, and potential effect of a multicomponent, community-based intervention aiming to improve quality of life (QoL) and function for older patients receiving radiotherapy (RT), and thereby reduce the needs for professional help. The intervention will be based on geriatric assessment and management (GAM), i.e. systematic assessment and management of physical, mental and functional problems frequently occurring in the elderly. It will target individual patients according to needs and be carried out in collaboration between hospital and community services from start of RT until 8 weeks post-treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Older Patients | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geriatric assessment with management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Geriatric assessment with management
- interventionNames
- Other: Geriatric assessment with management
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients receiving supportive care and follow up according to routine practice
Primary outcomes (1)
- measure
- physical function
- timeFrame
- 8 weeks following termination of radiotherapy (RT)
- description
- physical function as assessed by patient report using the EORTC QLQ-C30 questionnaire. The analysis will assess the difference between control and intervention groups in physical function measured by the EORTC QLQ-C30 questionnaire at 8 weeks after baseline. Longitudinal analysis of covariance will be performed by estimating a linear mixed model with fixed effects for baseline values, time and interaction between time and group variable. The model will include random effects for patients nested within study cluster.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ≥65 years of age * confirmed cancer diagnosis (histology/cytology) * living in one of the participating municipalities in the catchment area of Innlandet Hospital Trust or in the municipality of Trondheim * referred for palliative or curative RT * fluency in Norwegian, orally and in writing * ability to fill in self-report questionnaires * provide written informed consent Exclusion Criteria: * severely ill with a life expectancy \< 3months * referred to receive one fraction of RT only (one day treatment)
References
Publications (3)
- BACKGROUNDRoyset I, Saltvedt I, Rostoft S, Gronberg BH, Kirkevold O, Oldervoll L, Bye A, Benth JS, Bergh S, Melby L, Halsteinli V, Dohl O, Rostad T, Eriksen GF, Sollid MIV, Rolfson D, Slaaen M. Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study. J Geriatr Oncol. 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001. Epub 2021 Nov 12. PMID 34776384
- DERIVEDSollid MIV, Melby L, Slaaen M, Eilertsen G, Royset IM, Kirkevold O. Experiences With an Intervention Based on Geriatric Assessment With Management: A Qualitative Study. Nurs Open. 2025 Apr;12(4):e70220. doi: 10.1002/nop2.70220. PMID 40223637
- DERIVEDSlaaen M, Royset IM, Saltvedt I, Gronberg BH, Halsteinli V, Dohl O, Vossius C, Kirkevold O, Bergh S, Rostoft S, Oldervoll L, Bye A, Melby L, Rosstad T, Eriksen GF, Sollid MIV, Rolfson D, Saltyte Benth J. Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study. BMC Med. 2024 Jun 10;22(1):232. doi: 10.1186/s12916-024-03446-4. PMID 38853251